RSV Burden in Outpatient and Hospital Settings

NCT04743609 | Recruiting DMC

• 1 other identifier: 2020-A02876-33
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief Summary

Strengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)

Conditions

RSV Infection; Children, Only; Outpatient; Otitis

Keywords

RSV; children; otitis with or without concomitant bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Frequency of otitis media associated or not with bronchiolitis due to RSV in outpatient pediatrics

  Number of children presenting with confirmed otitis media, with or without bronchiolitis, attributable to respiratory syncytial virus (RSV)

  day of enrollment

Secondary Outcomes (7)

• Proportion of RSV positive acute otitis media cases with or without associated bronchiolitis in outpatient settings

  day of enrollment

• Impact of Nirsevimab on the burden of otitis media with or without bronchiolitis in outpatients

  day of enrollment

• Proportion of otitis media cases attributable to SARS-CoV-2 in outpatient settings

  day of enrollment

• Patient care pathway documentation

  day of enrollment, at days 15 and at 6 months after inclusion

• Score of Quality of life

  15 days and 6 months after inclusion

Study Arms (2)

Otitis associated with Bronchiolitis

EXPERIMENTAL

Only for city physicians: 800 children presenting with acute otitis media associated with bronchiolitis will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.

Diagnostic Test: nasopharyngeal samples

Otitis not associated with Bronchiolitis

EXPERIMENTAL

Only for city physicians: A total of 1,100 children presenting with acute otitis media, without concomitant bronchiolitis, will undergo a rapid antigen diagnostic test for respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2, using a nasopharyngeal swab.

Diagnostic Test: nasopharyngeal samples

Interventions

nasopharyngeal samples DIAGNOSTIC_TEST

rapid antigen test for Sars Cov-2, influenza and RSV.

Otitis associated with Bronchiolitis; Otitis not associated with Bronchiolitis

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children under 24 months of age (≤)
• One of the holders of parental authority signed the consent
• Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
• Acute purulent otitis media (Paradise Criteria) or otorrhea with or withitout associated bronchiolitis

You may not qualify if:

• Age \>24 months
• Refusal by one of the parents
• Not affiliated to a social security system
• Maternal RSV vaccination during the pregnancy of the included child

Sponsors & Collaborators

• Sanofi: collaborator
• Association Clinique Thérapeutique Infantile du val de Marne: lead

Study Sites (1)

ACTIV

Créteil, 94000, France

RECRUITING

Related Publications (3)

• Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270.

  PMID: 34260480 RESULT

• Lenglart L, Levy C, Basmaci R, Levieux K, Kramer R, Mari K, Bechet S, Launay E, Cohen L, Aupiais C, de Pontual L, Rybak A, Lassoued Y, Ouldali N, Cohen R. Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study. Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9.

  PMID: 39893316 RESULT

• Rybak A, Cohen R, Bangert M, Kramer R, Delobbe JF, Deberdt P, Cahn-Sellem F, Bechet S, Levy C. Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study. Pediatr Infect Dis J. 2024 Jul 1;43(7):657-662. doi: 10.1097/INF.0000000000004360. Epub 2024 Apr 10.

  PMID: 38900603 RESULT

Related Links

• Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021
• Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study
• Assessing the Burden of Respiratory Syncytial Virus-related Bronchiolitis in Primary Care and at 15-Day and 6-Month Follow-up Before Prophylaxis in France: A Test-negative Study

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Otitis

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Robert Cohen

  Association Clinique et Thérapeutique Infantile du Val de Marne

  STUDY DIRECTOR

Central Study Contacts

Corinne Levy, MD

CONTACT

0033148850404; corinne.levy@activ-france.fr

Stéphane Béchet, MsC

CONTACT

0033148850404; stephane.bechet@activ-france.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A nasopharyngeal specimen will be obtained from the eligible child. The procedure consists of inserting and gently rotating a swab into the posterior nasopharynx to perform a rapid antigen test (nasopharyngeal or nasal). The test provides results within 10 to 15 minutes and determines the presence or absence of respiratory syncytial virus (RSV), influenza viruses, and SARS-CoV-2.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 8, 2021
• Study Start: February 8, 2021
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available 12 months after publication of the primary results and will be accessible for 5 years
• Access Criteria: Access will be granted to qualified researchers after submission of a research proposal and approval by ACTIV. All shared data will be fully anonymized to protect participant confidentiality. Use of the data is restricted to scientific research purposes only

Locations

FR (1)